Status:
UNKNOWN
Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Allist Pharmaceuticals, Inc.
Conditions:
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC.
Eligibility Criteria
Inclusion
- Male or female subjects aged ≥18 years old;
- Locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology (stage ⅢB-Ⅳ, according to the 8th Edition of the AJCC Staging system);
- The tumour harbours one of the most common EGFR mutations (19del or L858R);
- The programmed death-ligand 1 (PD-L1) tumoral expression is positive;
- No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
- According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline;
- ECOG performance status score 0-2；
- Subjects have voluntarily participated, signed and dated informed consent.
Exclusion
- Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer;
- Subjects have no measurable tumor lesion at baseline;
- Subjects with spinal cord compression or symptomatic brain metastases;
- Subjects are suitable for surgery;
- Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents;
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>2.5 × ULN, or serum total bilirubin (TBIL)\>1.5 × ULN, or Cr\>1.0×ULN;
- Absolute value of neutrophil (ANC)\<1.5 × 109/L, or platelet (PLT) count\<75 × 109/L, or hemoglobin (HGB)\<90 g/L;
- Any of the following disease within 12 months: myocardial infarction, severe/unstable stenocardia, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident;
- Women who are pregnancy or lactation, or fertile but not using contraception;
- Suffering from other serious acute or chronic physical or mental problems;
- Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05255406
Start Date
December 9 2021
End Date
December 31 2024
Last Update
August 4 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032